Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

Advanced Adult Hepatocellular Carcinoma Clinical Trial

Official title:

A Pilot Study of Stereotactic Liver Irradiation for Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01899261
• Other study ID #: 2010-326
• Secondary ID: 2010-326P30CA013
• Status: Completed
• Phase: N/A
• Start date: October 7, 2010
• Est. completion date: May 2019

Study information

• Verified date: November 2022
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot clinical trial studies stereotactic body radiation therapy in treating patients with liver cancer that cannot be removed by surgery. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

Description:

PRIMARY OBJECTIVES:

I. To evaluate feasibility and safety of stereotactic body radiation therapy (SBRT) of the liver for treatment of hepatocellular carcinoma (HCC).

SECONDARY OBJECTIVES:

I. To evaluate radiographic local response, local control and time to local progression (TTLP) of treated lesions in HCC patients after liver SBRT.

II. To evaluate overall survival (OS) and cancer specific survival (CSS) in HCC patients treated with liver SBRT.

III. To evaluate explanted irradiated liver tissue (for patients who proceed to liver transplantation) to determine extent of residual tumor and extent of radiation effects within and around the irradiated field.

OUTLINE:

Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.

After completion of study treatment, patients are followed up at 1, 3, 6, 9, and 12 months and then every 6 months for up to 2 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2019
• Est. primary completion date: May 9, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Life expectancy > 3 months

• Eastern Cooperative Oncology Group (ECOG) performance status =< 2

• HCC diagnosed by either of the following approaches:

• Histologic confirmation of HCC on biopsy

• Evidence of vascular enhancement of suspected lesion on at least two imaging techniques

• Evidence of vascular enhancement on a single technique if the alpha-fetoprotein (AFP) is > 200 ng/mL in the setting of cirrhosis or chronic hepatitis B/C

• HCC must be deemed unresectable by an experienced surgeon or patient must be medically inoperable or extra-hepatic metastases must be present (making resection an inappropriate treatment option) or patient must have declined the option of surgery after consultation with a surgeon

• Barcelona Clinic Liver Cancer score of B or C required (i.e., intermediate or advanced stage HCC)

• Prior liver resection or ablative therapy is permitted

• Prior transarterial chemoembolization (TACE) is permitted

• Patients must have recovered from the effects of previous therapy

• Maximal tumor size of 15 cm and > 700 cc of uninvolved liver

• Hemoglobin > 9.0 g/L

• Absolute neutrophil count >= 1.0 bil/L

• Platelets >= 70,000 bil/L

• Total bilirubin < 2 mg/dL

• International normalized ratio (INR) =< 1.5 or correctable with vitamin K (higher INR acceptable if patient is on Coumadin)

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 6 times upper range of normal

Exclusion Criteria:

• Active hepatitis or encephalopathy related to liver failure

• Prior radiation therapy to the upper abdomen or thorax

• Lesions within 1 cm from the stomach

• Prior uncontrolled, life threatening malignancy within the previous 6 months

• Pregnancy is not permitted; women of child-bearing age must undergo pregnancy testing prior to enrollment

• Previous gastric, duodenal or variceal bleed within the past 2 months

• Thrombolytic therapy within 4 weeks or commencement of anticoagulant use within the past 3 months

Related Conditions & MeSH terms

• Adult Hepatocellular Carcinoma
• Advanced Adult Hepatocellular Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular
• Liver Neoplasms
• Localized Non-Resectable Adult Liver Carcinoma
• Recurrent Adult Liver Carcinoma

Intervention

Radiation:
• Stereotactic Radiosurgery
Undergo SBRT

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe Treatment-related Toxicity	The percentage of patients who have severe treatment-related toxicity will be computed, along with exact 95% confidence intervals. Severe toxicity will be defined as grade 4 or 5 hepatic toxicity, thrombocytopenia, or gastrointestinal toxicity, graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0	Within 3 months of SBRT
Secondary	Cancer Specific Survival (CSS)	Cancer Specific Survival (CSS) was assessed in patients who were diagnosed with HCC and treated with liver SBRT as the percentage of patients with Cause-Specific Death from HCC. Patients alive at the end of the follow-up period were censored. Competing risk analysis was performed.	Time from study entry to death from Hepatocellular Carcinoma (HCC) progression, assessed up to 2 years
Secondary	Overall Survival (OS)	Overall Survival, estimated using the Kaplan-Meier method, reflected the percentage of patients who were were diagnosed with HCC and started SBRT treatment and were still alive at the conclusion of the study.	Time from study entry to death from any cause, assessed up to 2 years
Secondary	Time to Local Progression (TTLP) of Treated Lesions	Time to Local progression (TTLP) of treated lesions in HCC patients after liver SBRT treatment was evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST). For patients who died from the study disease without progression of the radiated lesion, time to local progression was censored at the date of death. For patients not known to have died as of the data cut-off date, and who did not have locally progressive disease, time to local progression was censored at the last progression-free disease assessment.	From date of first treatment dose to the first date of objective local progressive disease as defined by RECIST criteria, assessed up to 2 years